Supplements are big business in the United States, accounting for, at a conservative estimate, around $5 billion in sales per year. They are also, thanks to a 1994 law called the Dietary Supplement Health and Education Act, almost completely exempt from the rigorous screening and regulations applied to drugs by the FDA. At best, supplements are required to include “disclaimers” when making certain health claims and are not allowed to say they “diagnose, treat, cure or prevent” diseases – claims that are legally limited to FDA-approved drugs. At worse, supplements may not contain their advertised ingredients and can contain undisclosed and dangerous substances.
That was the conclusion of New York Attorney General Eric Schneiderman, whose office took legal action in February 2015 against GNC, Target, Walmart and Walgreens after analyzing supplements bought at the stores and discovering that many of the products didn’t actually contain the advertised ingredients. According to Schneiderman, who was joined in his legal action by other state Attorneys General, herbal supplements commonly sold as St. John’s Wort, Ginseng, Garlic, Echinacea and others were often found to contain no DNA trace of the advertised herb. To quote one worrying section of the investigation, relating to Ginseng sold by GNC:
“No ginseng DNA was identified. The testing yielded identification of oryza, dracaena, pinus strobus, wheatgrass, and citric sap, with 15 of the tests identifying no generic material at all.”
In other cases, traces of ingredients not listed on the products were discovered, including potential allergens. “Cease and desist” notices were immediately sent to the retailers, demanding they withdraw the products from sale until the packaging accurately reflected the true nature of the supplements.
Sadly, that was only the beginning of the story.
Since February’s state investigation, supplement companies have come under increased scrutiny – and the results have been less than inspiring. In October of this year, the Oregon Attorney General filed a lawsuit against GNC alleging the company’s supplements contained harmful synthetic drugs that were undisclosed and unapproved. According to the suit, GNC’s fat-burner supplements, such as Meltdown and Redline brands, contained picamilon – used in Russia as a prescription drug to treat neurological conditions – and BMPEA (an amphetamine-like substance); both illegal substances that have no place anywhere near a “health” product. Just last week, the FDA ordered GNC and an additional four companies to stop selling supplements containing picamilon, saying the product labeling is “misleading.” The agency has apparently received almost a dozen reports of consumers affected by unknowingly taking what is, in essence, a prescription drug, and has now given the companies 15 days to comply with its order.
The companies and products affected by this month’s FDA order are:
- DBM Nutrition (DBM Endurance World Championship Countess)
- ICF International (Myokem Nitramine)
- Top Secret Nutrition (Pump Igniter)
- Applied Nutriceuticals (HG4UP)
- SDC Nutrition (NVIE Edge Pro)
Last month, U.S. Senator Claire McCaskill also voiced concerns about picamilon-tainted supplements, writing to some of the country’s largest retailers (including Amazon, Google, and Wal-Mart) urging them to stop selling the pills.
Many consumers are waking up to the reality that an industry protected by federal law from meaningful scrutiny is now in dire need of oversight.
The pressure on supplement makers is now continuing. Last month, federal prosecutors in California announced three lawsuits against supplement manufacturers accused of selling products using false and misleading claims. The first case focuses on Clifford Woods LLC, also known as Vibrant Life, which allegedly sold supplements (including Taheebo Life Tea, Life Glow Plus and Organic Sulphur) as treatments for Alzheimer’s disease and cancer. Prosecutors say the company effectively defrauded customers by selling unbranded – and, while we’re at it, entirely ineffective – drugs. The second lawsuit was filed against VivaChemicals Inc., selling in California as Regeneca Worldwide, and alleges that the company’s RegeneSlim supplements are produced in violation of FDA manufacturing requirements. The supplements also allegedly contain undisclosed ingredients, including an unsafe food additive, diimethylamylamine, which can cause potentially dangerous narrowing of blood vessels.
In a third lawsuit, the Department of Justice prosecutors accuse supplement maker USPlabs of importing Chinese-made ingredients and lying about their provenance after adding them to its products.
When sold and used properly, supplements can be a great way of ensuring you get the support you need. The problem comes when there’s a breakdown between consumers’ expectations and a product’s reality. Is the solution extended FDA oversight? The agency is famously sluggish and slow to respond to innovation and it seems unlikely that a supplement industry taken under the FDA’s wing would be particularly successful. On the other hand, there’s a clear need for change and lawsuits are only a short-term fix and cannot (and should not) be seen as an alternative to government regulation.
Supplements are big business – but with that comes big responsibility and, if manufacturers cannot deliver the promises their products make, then things won’t stay the same for long.